SUPPLY CHAIN ARTICLES
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Multidisciplinary mRNA: What Can We Learn From Other CGTs?
Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.
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Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault
What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.
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What Violin Making Can Teach Us About mRNA Therapeutic Quality
Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.
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“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA
It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).
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Defining The RNA Therapeutics Industry In 2023
Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
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mRNA Vaccines: Key Considerations For Development & Manufacturing
As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
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Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
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Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
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Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.